A pilot study of adipokines and calorie restriction in Multiple Sclerosis
Multiple sclerosis (MS) is an inflammatory disease of the central nervous system (CNS) mediated by immune and neurodegenerative mechanisms. It is a major cause of disability in young adults. Risk of MS is increased about twofold by a high body mass index (BMI). Fat tissue is a source of molecules, collectively known as adipokines that can regulate immune and inflammatory responses.
The purpose of this study is to investigate the effects of a regimen of calorie restriction (achieved by alternate day fasting) in MS patients experiencing a relapse on several blood factors and clinical outcomes.
We will enroll eligible relapsing-remitting MS patients (18-60 years of age) having an MS attack. Enrolled subjects will be randomized to either:
- Every other day calorie restriction (CR) plus intravenous corticosteroid for three days and an oral corticosteroid taper for a week afterwards (ten total days). The steroid treatment is a standard therapy for significant MS relapses.
- the same steroid regimen as above but without the calorie restriction (control group)
At the end of the Acute CR phase, both groups will be offered to enroll in the alternate day fasting regimen for six months (Chronic CR phase).
- BMI less than 23
- Chronic disease (excluding MS) that could interfere with interpretation of results
- Use of insulin pumps or insulin injections for diabetes
- Use of drugs like Warfarin or Coumadin that need to monitor the intake of vegetables containing high levels of vitamin K
- Alcoholism, psychiatric problems, life situations that would interfere with study participation and compliance
- Patients that are medically required to follow a special diet or food restriction (diabetic, gastric bypass, soft/pureed food, etc.)
Length of trial
Participants will be in the Acute CR phase for 15 days. If participant will decide to be enroll in the Chronic CR phase, the trial will last six months